Devices and methods for fixation of bodily implants

ABSTRACT

A medical device includes an elongate member configured to be at least partially disposed within a body of a patient. The elongate member has an outer surface. The outer surface of the elongate member has a first ridge and a second ridge.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Nonprovisional of, and claims priority to, U.S.Patent Application No. 61/975,379, filed on Apr. 4, 2014, entitled“DEVICES AND METHODS FOR FIXATION OF BODILY IMPLANTS”, which isincorporated by reference herein in its entirety.

TECHNICAL FIELD

This disclosure relates generally to medical devices and surgicalprocedures, and more particularly to medical devices and methods used toimplant and attach bodily implants within a body of a patient.

BACKGROUND

Bodily implants, such as mesh implants, are sometimes placed within abody of a patient. For example, sometimes implants are placed within abody of a patient to provide support to portions of the body of thepatient. Implants may be placed within a pelvic region of a patient toprovide support to portions of the pelvic region of the patent.

In some procedures for placing implants within a body of a patient, animplant is anchored or secured to bodily tissue. In some cases, it isdesirable to limit or to control the depth of penetration of the anchoror other device used to couple or attach the implant within the body ofthe patient. For example, in some sacral colpopexy procedures, animplant is coupled to an outer surface of a vaginal wall of a patient.It can be desirable to control or limit the depth of penetration of theanchor or other device used to couple the implant to the outer surfaceof the vaginal wall. For example, it can be desirable to prevent theanchor or other device use to couple or attach the implant frompenetrating into the vagina (or otherwise penetrate completely throughthe vaginal wall).

Accordingly, there is a need for medical devices and methods that allowfor effective and efficient implant placement. For example, there is aneed for devices and methods that allow for or help control the depth ofpenetration of an anchoring mechanism used to couple or attach animplant within a body of a patient.

SUMMARY

In one embodiment, a medical device includes an elongate memberconfigured to be at least partially disposed within a body of a patient.The elongate member has an outer surface. The outer surface of theelongate member has a first ridge and a second ridge.

In another embodiment, a medical device includes an elongate member andan expander. The expander defines a lumen and is slidably coupled to theelongate member. The expander has a proximal end portion and a distalend portion. The distal end portion of the expander has a taperedsection.

In another embodiment, a method of placing an implant within a body of apatient includes inserting a manipulator within a vagina of a patient;disposing the implant adjacent a vaginal wall of the patient; moving afirst portion of the manipulator with respect to a second portion of themanipulator to expand the vagina of the patient; and attaching theimplant to the vaginal wall of the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of a system according to an embodiment ofthe invention.

FIG. 2 is a perspective view of an anchor according to an embodiment ofthe invention.

FIG. 3 is a side view of the anchor of FIG. 2 is an open configuration.

FIG. 4 is a side view of the anchor of FIG. 2 in a closed configuration.

FIG. 5 is a perspective view of a device for delivering the anchor ofFIG. 2 according to an embodiment of the invention.

FIG. 6 is a perspective view of an anchor according to an embodiment ofthe invention.

FIG. 7 is a side view of the anchor of FIG. 6 in an open configuration.

FIG. 8 is a side view of the anchor of FIG. 6 in a closed configuration.

FIG. 9 is a perspective view of a device for delivering the anchor ofFIG. 10.

FIG. 10 is a perspective view of an anchor according to an embodiment ofthe invention.

FIG. 11 is a schematic illustration of an anchor of FIG. 10 disposedwithin a body of a patient.

FIG. 12 is perspective view of a device for delivering an anchor of FIG.10.

FIG. 13 is a perspective view of a manipulator according to anembodiment of the invention.

FIG. 14 is a cross-sectional view of the manipulator of FIG. 13.

FIG. 15 is a schematic view of the manipulator of FIG. 13 disposedwithin a body of a patient.

FIG. 16-18 are schematic views of a systems according to embodiments ofthe invention.

FIG. 19 is a perspective view of a manipulator according to anembodiment of the invention.

FIG. 20 is a perspective view of a portion of the manipulator of FIG.19.

FIG. 21 is a perspective view of an implant according to an embodimentof the invention.

FIGS. 22 and 23 are perspective views of a manipulator according to anembodiment of the invention.

FIGS. 24-27 are schematic views of a process of using a system inaccordance with an embodiment of the invention.

FIG. 28 is a flow chart of a method according to an embodiment of theinvention.

DETAILED DESCRIPTION

Detailed embodiments are disclosed herein. However, it is understoodthat the disclosed embodiments are merely examples, which may beembodied in various forms. Therefore, specific structural and functionaldetails disclosed herein are not to be interpreted as limiting, butmerely as a basis for the claims and as a representative basis forteaching one skilled in the art to variously employ the embodiments invirtually any appropriately detailed structure. Further, the terms andphrases used herein are not intended to be limiting, but to provide anunderstandable description of the invention.

The terms “a” or “an,” as used herein, are defined as one or more thanone. The term “another,” as used herein, is defined as at least a secondor more. The terms “including” and/or “having”, as used herein, aredefined as comprising (i.e., open transition). The term “coupled” or“moveably coupled,” as used herein, is defined as connected, althoughnot necessarily directly and mechanically.

In general, the embodiments are directed to systems, methods, anddevices for placing implants within in body of a patient. For example,the systems, methods, and devices may be used in various types ofprocedures, such as procedures for treating female pelvic prolapse oranal prolapse in males or females. Also, the systems, methods, anddevices described herein may be used in transabdominal and/ortransvaginal procedures.

The term patient may hereafter be used for a person who benefits fromthe medical device or the methods disclosed in the present application.For example, the patient can be a person whose body is operated throughthe medical device or the method disclosed by the present invention. Forexample, in some embodiments, the patient may be a human female, a humanmale, or any other mammal.

The terms proximal and distal described in relation to various devices,apparatuses, and components as discussed in the subsequent text of thepresent application are referred with a point of reference. The point ofreference, as used in this description, is a perspective of an operator.The operator may be a surgeon, a physician, a nurse, a doctor, atechnician, and the like who may perform the procedure and operate themedical device as described in the present invention. The term proximalrefers to an area or portion that is closer or closest to the operatorduring a surgical procedure. The term distal refers to an area orportion that is farther or farthest from the operator.

FIG. 1 is a schematic diagram of a system 100 according to an embodimentof the invention. The system 100 may be used to couple or attach abodily implant within a body of a patient. The system 100 includes ananchor or coupling member 110, an insertion device 120, and amanipulator 130.

The anchor or coupling member 110 is configured to engage a bodilyimplant I and help retain the bodily implant I in place within the bodyof the patient. In some embodiments, the anchor or coupling member 110engages the bodily implant I and bodily tissue BT to retain the implantI in place within the body with respect to the bodily tissue BT. In someembodiments, the bodily tissue BT is tissue located in the pelvic regionof a patient. For example, in some embodiments, the bodily tissue BT isa vagina or a vaginal wall of a patient. The implant I may be of anyshape or size. In some embodiments, the implant I includes a meshportion.

In some embodiments, the anchor or coupling member 110 includes a hook,barb, or extension portion that is configured to extend through theimplant I and into the bodily tissue BT to couple or help couple theimplant I to the bodily tissue BT. In other embodiments, the anchor orcoupling member 110 is a suture or other type of coupling device.

In some embodiments, the anchor or coupling member 110 is configured tohave a limited penetration depth into the bodily tissue BT. In someembodiments, the anchor or coupling member 110 is configured or sized topenetrate less than five millimeters (5 mm) of bodily tissue. In otherembodiments, the anchor or coupling member 110 is configured topenetrate more than five millimeters (5 mm) of bodily tissue. In somecases the bodily tissue BT is a vagina or a vaginal wall of a patient.In some embodiments, the anchor or coupling member 110 is configured tocouple the implant I to the vagina or the vaginal wall or tissue nearthe vaginal wall without extending through the vaginal wall into thevaginal canal of the patient.

The anchor or coupling member 110 may be formed of any type ofbiocompatible material. In some embodiments, the anchor or couplingmember 110 may be formed of a bioresorbable material. In someembodiments, the system 100 may include more than one anchor or couplingmember 110 to secure or couple the implant I within the body of thepatient.

The insertion device 120 is configured to facilitate the placement ofthe anchor or coupling member 110 within the body of the patient. Insome embodiments, the insertion device 120 is configured to engage theanchor 110 and insert the anchor 110 into position with the body of thepatient. Once the anchor 110 is disposed in the appropriate location,the anchor 110 can be disengaged from the insertion device 120 and theinsertion device 120 can be removed from the body of the patient.

In some embodiments, the insertion device 120 may be inserted into thebody via an abdominal incision. In other embodiments, the insertiondevice 120 may be inserted into the body via other locations of thebody, such as via a vaginal opening or a vaginal incision or other typeof incision.

The manipulator 130 is configured to manipulate bodily tissue. In someembodiments, the manipulation of the tissue facilitates the placement orsecurement of the bodily implant I within the body of the patient. Forexample, in some embodiments, the manipulator 130 is configured to beinserted into the body of the patient and manipulate the bodily tissueBT so as to facilitate the securement of the bodily implant I to thebodily tissue BT.

In some embodiments, the manipulator 130 is configured to be insertedinto a vagina of the patient and to manipulate the vaginal tissue orvaginal walls of the patient. In some cases, such manipulation of thevagina or the vaginal walls facilitates the placement of the implant ina correct location with respect the vagina and the securement of theimplant to the vagina or tissue proximate the vagina via the anchor 110.

The manipulator 130 may be formed of any type of biocompatible material.The manipulator 130 may be configured to be inserted into any portion ofthe body of the patient and may be configured to be inserted into thebody via any opening or incision.

FIGS. 2-4 illustrate an anchor or coupling member 210 in accordance withan embodiment of the invention. The anchor or coupling member 210 isconfigured to engage a bodily implant I and help retain the bodilyimplant I in place within the body of the patient. Specifically as bestillustrated in FIG. 4, the anchor or coupling member 210 engages thebodily implant I and bodily tissue BT to retain the implant I in placewithin the body with respect to the bodily tissue BT. In someembodiments, the bodily tissue BT is tissue located in the pelvic regionof a patient. For example, in some embodiments, the bodily tissue BT isa vagina or a vaginal wall of a patient.

In the illustrated embodiment, the anchor or coupling member 210 a baseportion 216 and extension portions 212 and 214 that are configured toextend through the implant I and into the bodily tissue BT to couple orhelp couple the implant I to the bodily tissue BT. The extensionportions 212 and 214 may be configured to move or bend with respect tothe base portion 216. For example, the extension portion 212 and 214 maybe configured to be inserted into the body and through the bodily tissueBT while the extension portions 212 and 214 are in a first position orconfiguration (as illustrated in FIG. 3). Once the anchor 210 is inplace within the body, the extension portions 212 and 214 may move to asecond position or configuration (as illustrated in FIG. 4).

In some embodiments, the anchor or coupling mechanism 210 may beinserted into the body of the patient using an insertion device 220 asillustrated in FIG. 5. The insertion device 220 may be configured tograsp or hold the anchor or coupling mechanism 210 while the insertiondevice 220 and the anchor 210 are inserted into the body of the patient.The insertion device 220 may be configured to then squeeze or crimp theanchor 210 into its second or closed position. For example, in someembodiments, the insertion device 220 may be configured to grasp theanchor 210 using grip portions 222 and 224 and squeeze the anchor 210 ator near the junction of the extension members 212 and 214 and the baseportion 216 or on the extension members 212 and 214 themselves to movethe extension members 212 and 214 to their second positions.

In other embodiments, a different type of device may be used to deliverthe anchor 210 into position within the body of the patient. In someembodiments, the delivery device may be configured to retain or holdmore than one anchor 210. In such embodiments, the delivery device andthe plurality of anchors may be inserted into the body. One the anchorsmay be placed within the body at different locations and may be placedserially without having to remove the delivery device from the body ofthe patient.

In some embodiments, the anchor or coupling member 210 is configured tohave a limited penetration depth into the bodily tissue BT. For example,in some cases the bodily tissue BT is a vagina or a vaginal wall of apatient. In some embodiments, the anchor or coupling member 110 isconfigured to couple the implant I to the vagina or the vaginal wallwithout extending through the vaginal wall into the vaginal canal of thepatient. As best illustrated in FIG. 4, in the illustrated embodiment,extension portions 212 and 214 of the anchor 210 do not extend thoughthe bodily tissue BT.

The anchor or coupling member 210 may be formed of any type ofbiocompatible material. For example, in some embodiments, the anchor 210is formed of a material that may be bent or reshaped and is configuredto hold the shape in which it is placed until it is changed. Forexample, in some embodiments, the anchor 210 may be placed such that theextension portions 212 and 214 are in their first positions orconfigurations and the anchor 210 will stay in such a position. Theextension portions 212 and 214 may then be moved to their secondpositions or configurations and the anchor 210 will stay in such aposition. In other embodiments, the anchor or coupling member 210 isformed of a shape memory material. In some embodiments, the anchor orcoupling member 210 is formed of a material has a biased configuration(such as biasing the anchor or extension portions to one of the firstposition or second position).

FIGS. 6-8 illustrate an anchor or coupling member 310 in accordance withan embodiment of the invention. FIGS. 7 and 8 illustrate the anchor orcoupling member 310 along with a portion of a insertion or deliverydevice 320 (as described in more detail below) shown see-though so as toshow the internal components. The anchor or coupling member 310 isconfigured to engage a bodily implant and help retain the bodily implantin place within the body of the patient. Specifically, the anchor orcoupling member 310 engages the bodily implant and bodily tissue toretain the implant in place within the body with respect to the bodilytissue. In some embodiments, the bodily tissue is tissue located in thepelvic region of a patient. For example, in some embodiments, the bodilytissue is a vagina or a vaginal wall of a patient.

In the illustrated embodiment, the anchor or coupling member 310 a baseportion 316 and extension portions 312 and 314 that are configured toextend through the implant and into the bodily tissue to couple or helpcouple the implant to the bodily tissue. The extension portions 312 and314 may be configured to move or bend with respect to the base portion316. For example, the extension portion 312 and 314 may be configured tobe inserted into the body and through the bodily tissue while theextension portions 312 and 314 are in a first position or configuration(as illustrated in FIG. 7). Once the anchor 310 is in place within thebody, the extension portions 312 and 314 may move to a second positionor configuration (as illustrated in FIG. 8).

In some embodiments, the anchor or coupling mechanism 310 may beinserted into the body of the patient using an insertion device 320 asillustrated in FIG. 9 (and partially illustrated in FIGS. 7 and 8). Theinsertion device 320 may be configured to retain the coupling mechanism310 within a lumen 322 defined by the insertion device 320 while theinsertion device 320 and the anchor 310 are inserted into the body ofthe patient. The insertion device 320 may be configured to then push orforce the anchor 310 out of the lumen 322. For example, in theillustrated embodiment, a pusher 324 may be moved by the operator orphysician (such as via the actuator 329 extending from a proximal endportion of the insertion device 320), to force or push the anchor 310out of the lumen 322. In the illustrated embodiment, the pusher 324 isshaped such that it is configured to force or cause the extensionportions 312 and 314 into their second position (as illustrated in FIG.8). Specifically, the pusher 324 includes engagement portions 326 and328 that are configured to contact the anchor 310 and cause theextension portions 312 and 314 to move to their second positions.

In other embodiments, a different type of device may be used to deliverthe anchor 310 into position within the body of the patient. In someembodiments, the delivery device may be configured to retain or holdmore than one anchor 310. In such embodiments, the delivery device andthe plurality of anchors may be inserted into the body. The anchors maybe placed within the body at different locations and may be placedserially without having to remove the delivery device from the body ofthe patient.

In some embodiments, the anchor or coupling member 310 is configured tohave a limited penetration depth into the bodily tissue. For example, insome cases the bodily tissue is a vagina or a vaginal wall of a patient.In some embodiments, the anchor or coupling member 310 is configured tocouple the implant to the vagina or the vaginal wall without extendingthrough the vaginal wall into the vaginal canal of the patient.

The anchor or coupling member 310 may be formed of any type ofbiocompatible material. Specially, in some embodiments, the anchor orcoupling member 310 is formed of titanium. In some embodiments, theanchor 310 is formed of a material that may be bent or reshaped and isconfigured to hold the shape in which it is placed until it is changed.For example, in some embodiments, the anchor 310 may be placed such thatthe extension portions 312 and 314 are in their first positions orconfigurations and the anchor 310 will stay in such a position. Theextension portions 312 and 314 may then be moved to their secondpositions or configurations and the anchor 310 will stay in such aposition. In other embodiments, the anchor or coupling member 310 isformed of a shape memory material. In some embodiments, the anchor orcoupling member 310 is formed of a material has a biased configuration(such as biasing the anchor or extension portions to one of the firstposition or second position).

FIGS. 10 and 11 illustrate an anchor or coupling member 410 inaccordance with an embodiment of the invention. The anchor or couplingmember 410 is configured to engage a bodily implant and help retain thebodily implant in place within the body of the patient. Specifically,the anchor or coupling member 410 engages the bodily implant I andbodily tissue BT to retain the implant in place within the body withrespect to the bodily tissue BT. In some embodiments, the bodily tissueBT is tissue located in the pelvic region of a patient. For example, insome embodiments, the bodily tissue BT is a vagina or a vaginal wall ofa patient.

In the illustrated embodiment, the anchor or coupling member 410 a baseportion 416 and retention portions 412 and 414. The base portion 416 isconfigured to extend through the implant and into the bodily tissue andthe retention portions 412 and 414 are configured to help retain theanchor 410 in place within the body of the patient.

In some embodiments, the anchor or coupling mechanism 10 may be insertedinto the body of the patient using an insertion device 420 asillustrated in FIG. 12. The insertion device 420 may be configured toretain the coupling mechanism 410 within a lumen defined by a needleportion 422 of the insertion device 420 while the insertion device 420and the anchor 410 are inserted into the body of the patient. Theinsertion device 420 may be configured to then push or force the anchor410 out of the lumen. For example, in the illustrated embodiment, apusher may be moved by the operator or physician (such as by moving oractuating the actuator 429), to force or push the anchor 410 out of thelumen defined by the needle portion 422 of the delivery device 420. Insome embodiments, the delivery device 420 is configured to push or forcethe anchor 410 from the needle portion 422 while one of the retentionportions is in a collapsed or folded configuration.

In the illustrated embodiment, the delivery device 420 is configured toretain or hold more than one anchor 410. Accordingly, the deliverydevice and the plurality of anchors may be inserted into the body. Theanchors may be placed within the body at different locations and may beplaced serially without having to remove the delivery device from thebody of the patient. In other embodiments, a different type of devicemay be used to deliver the anchor 410 into position within the body ofthe patient.

In some embodiments, the anchor or coupling member 410 is configured tohave a limited penetration depth into the bodily tissue. For example, insome cases the bodily tissue is a vagina or a vaginal wall of a patient.In some embodiments, the anchor or coupling member 410 is configured tocouple the implant to the vagina or the vaginal wall without extendingthrough the vaginal wall into the vaginal canal of the patient.

The anchor or coupling member 410 may be formed of any type ofbiocompatible material.

FIGS. 13-15 illustrate a manipulator 530 according to an embodiment ofthe invention. The manipulator 530 is configured to be inserted into thebody of the patient and manipulate or move bodily tissue. In someembodiments, the manipulation of the bodily tissue facilitates theplacement or securement of the bodily implant within the body of thepatient. For example, in some embodiments, the manipulator 530 isconfigured to be inserted into the body of the patient and manipulatethe bodily tissue so as to facilitate the securement of the bodilyimplant to the bodily tissue.

The manipulator 530 includes an elongate member 532. The elongate member532 has a proximal end portion 536 and a distal end portion 538. Theelongate member has an outer surface 534 and defines a longitudinal axisA.

In the illustrated embodiment, the outer surface 534 of the manipulator530 includes undulations or otherwise has a non-smooth surface.Specifically, in the illustrated embodiment, the outer surface 534 ofthe manipulator 530 includes or defines a first ridge or bump 582 and asecond ridge or bump 584. The first ridge or bump 582 and the secondridge or bump 584 are disposed at the distal end portion 538 of themanipulator 530. The first ridge or bump 582 and the second ridge orbump 584 extend along the outer surface 534 of the manipulator indirections that are parallel to the longitudinal axis A of themanipulator 530. In other embodiments, the ridges or bumps may extend indirections that are not parallel to the longitudinal axis of themanipulator 530. Also, in other embodiments, the ridges or bumps mayextend the entire length of the manipulator.

The outer surface 534 of the manipulator 530 includes or defines troughsor indentations 592, 594, and 596. The troughs or indentations 592, 594,and 596 are disposed at the distal end portion 538 of the manipulator530. The troughs or indentations 592, 594, and 596 extend in directionsthat are parallel to the longitudinal axis A of the manipulator 530. Inthe illustrated embodiment, the troughs or indentations 592, 594, and596 are disposed adjacent the ridges or bumps 582 and 584. In otherembodiments, the troughs or indentations may extend in directions thatare not parallel to the longitudinal axis of the manipulator 530. Also,in other embodiments, the troughs or indentations may extend the entirelength of the manipulator.

FIG. 14 is a cross-sectional view of the manipulator 530 taken alongline B-B of FIG. 13 (line B-B extends perpendicular to the longitudinalaxis A of the manipulator 530). As best illustrated in FIG. 14, thefirst ridge or bump 582 and the second ridge or bump 584 extend adistance from the longitudinal axis A that is greater than otherportions of the outer surface 534 of the manipulator 530. For example,the ridges or bumps extend a distance from the longitudinal axis A thatis greater than the distance that the troughs or indentations extendfrom the longitudinal axis A.

In the illustrated embodiment, the manipulator 530 is configured to beinserted into a vagina of the patient and to manipulate the vaginaltissue or vaginal walls of the patient. Specifically, the manipulator530 may be inserted into the vagina of the patient such that distal endportion 538 is disposed within the vagina. The proximal end portion 536may extend from the vagina and allow the physician to control themovement of the manipulator 530. As best illustrated in FIG. 15, thevaginal wall VW of the vagina of the patient conforms to the contour orouter surface 534 of the manipulator 530. Specifically, the vaginal wallVW extends over the ridges or bumps 582 and 584 and depress or fold intothe troughs or indentations 592, 594, and 596.

In some cases, such manipulation of the vagina or the vaginal wall VWfacilitates the placement of the implant in a correct location withrespect the vagina and the securement of the implant to the vagina ortissue proximate the vagina via the anchor. For example, a delivery tool(such as a needle) or an anchor may be inserted into the vaginal wall VWalong the line C of FIG. 15 to couple the anchor to the vaginal wall VWbut not extend to the vaginal canal of the patient. In some embodiments,the manipulator 530 may be inserted into that vagina of the patient andthe delivery tool (or anchor) may be inserted into the body via anabdominal incision.

FIGS. 16 and 17 schematically illustrate a delivery tool 620 deliveringan anchor to the vaginal wall VW while the manipulator 530 is disposedwithin the vagina of the patient. The anchor delivered by the deliverytool 620 is configured to extend through the implant I and retain theimplant in place within the body of the patient. The delivery tool 620includes a needle portion 622 that is configured to move with respect tothe reminder of the delivery tool 620. For example, the needle portion622 may be configured to move once an actuator is actuated. For example,the delivery tool may include an actuator that is configured to actuateor move the needle portion 622 with respect to the remainder of thedelivery tool 620. In some embodiments, the delivery tool 620 or theneedle portion of the delivery tool 620 may be configured to deliver theanchor or coupling member in a manner similar to delivery tool 420.

In the illustrated embodiment, the delivery tool 620 includes a needleguard 629. The needle guard 629 is configured to guard or protect theneedle portion 622 during insertion of the delivery device 620 into thebody of the patient. The needle guard 629 also functions as a depthcontrol mechanism. Specifically, the needle guard 629 helps prevent theneedle portion 622 from penetrating too deep into the bodily tissue. Asbest illustrated in FIG. 16, the deliver tool 620 may be disposed suchthat the portion of the vaginal wall that extends over one of the ridges584 is disposed proximal the needle portion 622 and within are areadefined by the needle guard 629. The needle portion 622 may then beactivated to pierce the tissue and deliver the anchor 610.

While FIG. 16 illustrates delivery tool 620 being used to deliver theanchor to the bodily tissue, in other embodiments, other delivery toolsmay be used to deliver the anchor to the bodily tissue.

As illustrated in FIG. 17, multiple or a plurality of anchors may becoupled to the vaginal wall along the length of the ridge. Asillustrated in FIG. 18, anchors may be coupled to the vaginal wall alongthe length of both of the ridges. In other embodiments, the manipulatormay have more than two ridges. In such embodiments, anchors may beplaced along the length or adjacent to any number of the ridges.

The manipulator 530 may be formed of any type of biocompatible material.The manipulator 530 may be configured to be inserted into any portion ofthe body of the patient and may be configured to be inserted into thebody via any opening or incision.

FIGS. 19 and 20 illustrate a manipulator 730 according to anotherembodiment of the invention. The manipulator 730 is configured to beinserted into the body of the patient and manipulate or move bodilytissue. In some embodiments, the manipulation of the bodily tissuefacilitates the placement or securement of the bodily implant within thebody of the patient. For example, in some embodiments, the manipulator730 is configured to be inserted into the body of the patient andmanipulate the bodily tissue so as to facilitate the securement of thebodily implant to the bodily tissue.

The manipulator 730 includes an elongate member 732. The elongate memberhas a proximal end portion and a distal end portion. The elongate memberhas an outer surface and defines a longitudinal axis D.

In the illustrated embodiment, the outer surface of the manipulator 730includes undulations or otherwise has a non-smooth surface.Specifically, in the illustrated embodiment, the outer surface of themanipulator 730 includes or defines a first ridge or bump and a secondridge or bump. The first ridge or bump and the second ridge or bump aredisposed at the distal end portion of the manipulator 730. The firstridge or bump and the second ridge or bump extend along the outersurface 734 of the manipulator in directions that are parallel to thelongitudinal axis D of the manipulator 730. In other embodiments, theridges or bumps may extend in directions that are not parallel to thelongitudinal axis of the manipulator 730. Also, in other embodiments,the ridges or bumps may extend the entire length of the manipulator.

The outer surface of the manipulator 730 includes or defines troughs orindentations 792, 794, and 796. The troughs or indentations 792, 794,and 796 are disposed at the distal end portion 738 of the manipulator730. The troughs or indentations 792, 794, and 796 extend in directionsthat are parallel to the longitudinal axis D of the manipulator 730. Inthe illustrated embodiment, the troughs or indentations 792, 794, and796 are disposed adjacent the ridges or bumps. In other embodiments, thetroughs or indentations may extend in directions that are not parallelto the longitudinal axis of the manipulator 730. Also, in otherembodiments, the troughs or indentations may extend the entire length ofthe manipulator.

The manipulator 730 defines lumens 711, 713, and 715. The lumens 711,713, and 715 extend from the proximal end portion of the manipulator 730to the troughs 792, 794, and 796, respectively. Specifically, asillustrated in FIG. 19, the proximal end portion of the manipulator 730defines openings 721, 723, and 725. The manipulator 730 also definesopenings 731, 733, and 735 at locations proximate to, adjacent to, orwithin the troughs 792, 794, and 796. The lumens 711, 713, and 715 eachextend from an opening defined by the proximal end portion of themanipulator 730 to an opening defined by the manipulator 730 near thetroughs 792, 794, and 796.

The lumens are configured to be operatively coupled to a vacuum sourceVS. For example, a vacuum source VS or sources may be operativelycoupled to the lumens via the openings defined by the manipulator 730near the proximal end of the manipulator 730. For example, a couplingdevice CO may operatively couple a vacuum source VS to the lumens.

In the illustrated embodiment, the manipulator 730 is configured to beinserted into a vagina of the patient and to manipulate the vaginaltissue or vaginal walls of the patient. Specifically, the manipulator730 may be inserted into the vagina of the patient such that distal endportion is disposed within the vagina. The proximal end portion mayextend from the vagina and allow the physician to control the movementof the manipulator 730. Once the manipulator 730 is in place within thevagina the vacuum source may be activated or turned on to create avacuum through the lumens 711, 713, and 715. In some embodiments, thevacuum may facilitate the conforming of the vaginal wall to the outersurface of the manipulator 730. Once the procedure is completed, thevacuum source may be removed or turned off and the manipulator 730 maybe removed from the body of the patient.

FIG. 21 illustrates an implant 810 that may be inserted into a body of apatient. The implant 810 has a first end portion 812 and a second endportion 814 and defines a lumen 816 that extends from the first endportion 812 to the second end portion 814. In the illustratedembodiment, the implant 810 is formed of a mesh material. In otherembodiments, the implant 810 may be formed of any biocompatiblematerial.

The implant 810 may be used in any portion of the body. In someembodiments, the implant 810 is used to provide support to a portion ofthe body of the patient. In some embodiments, the implant 810 isconfigured to be disposed within a pelvic region of the patient and isconfigured to provide support to a vagina of the patient. For example,as discussed in further detail below, the implant 810 may be used in asacral colpopexy procedure.

FIGS. 22 and 23 illustrate a manipulator 830 according to an embodimentof the invention. The manipulator includes a first member or portion, anelongate member 832 and a second member or portion, an expander 834. Theelongate member 832 includes a proximal end portion 852 and a distal endportion 854.

The expander 834 includes a proximal end portion 862 and a distal endportion 864. The expander 834 defines a lumen that extends from theproximal end portion 862 of the expander 834 to the distal end 864 ofthe expander 834. The expander 834 is movably coupled to the elongatemember 832. Specifically, the lumen defined by the expander 834 isconfigured to receive the elongate member 832 such that the expander 834is slidably coupled to the elongate member 832.

The expander 834 is configured to slide into any number of positionswith respect to the elongate member 832. The expander 834 is configuredto be disposed in a retracted configuration or position (as illustratedin FIG. 22) and be moved to an extended configuration or position (asillustrated in FIG. 23).

In the illustrated embodiment, the elongate member 832 includes ordefines a handle or grip portion 856. The handle or grip portion 856 islarger in diameter or width than the reminder of the elongate member.

In the illustrated embodiment, the expander 834 includes or defines ataper portion 866. The taper portion 866 tapers from a larger section onthe proximal side of the taper portion 866 to a smaller side on thedistal side of the taper portion. Accordingly, in some embodiments, thetaper portion 866 helps facilitate the insertion or movement of theexpander 834 in the body of the patient. In some embodiments, theexpander includes a handle portion disposed at or near the proximal endportion 862.

FIGS. 24-27 schematically illustrated a process or method for disposingan implant into a body of a patient according to an embodiment of theinvention. Additionally, FIG. 28 is a flow chart that details the stepsof the process or method 900. As illustrated in FIG. 24 (at 910 of FIG.28), the manipulator 830 may be inserted into the body of the patientvia the vagina V of the patient. The manipulator 830 may be insertedinto the body while the manipulator 830 is in its retractedconfiguration or position (as shown in FIG. 22). As illustrated in FIG.24, the implant 810 may also be inserted into the body of the patient.The implant 810 in some cases is inserted into the body via an abdominalincision.

As illustrated in FIG. 25 (at 920 of FIG. 28), the implant 810 may bepositioned or fit over the vagina. For example, the vagina may be placedinto the lumen 816 defined by the implant 810.

As illustrated in FIG. 26 (at 930 of FIG. 28), the expander 834 of themanipulator 830 may be moved or slid to its extended or expandedconfiguration (as illustrated in FIG. 23). The placement of the expander834 within the vagina of the patent will cause the vagina to stretch orexpand and will tension the implant 810 against the walls of the vagina.The implant 810 can then be secured to the vaginal walls. For example,in some embodiments, an anchor or coupling mechanism may be used tocouple or secure the implant 810 to the vaginal walls. In someembodiments, the implant 810 may be coupled to the anterior vaginal wall(or tissue proximate or near the anterior vaginal wall) and may also becoupled to the posterior vaginal wall (or tissue proximate or near theposterior vaginal wall). In other embodiments, a suture or othercoupling mechanism may be used. In some embodiments, the implant 810 iscoupled to the vaginal walls via a laparoscopic procedure or anabdominal incision.

As illustrated in FIG. 27 (at 940 of FIG. 28), the expander 834 may bemoved back to its refracted configuration (as illustrated in FIG. 22).In some embodiments, a portion of the expander 834 remains outside ofthe body of the patient to facilitate the grasping and moving of theexpander 834. In some embodiments, the implant 810 is coupled to thesacrum or tissue proximate the sacrum. The attachment of the implant 810to the sacrum may be done via an anchor, a suture, or any other couplingmechanism. Additionally, in some embodiments, the implant 810 is cut toremove excess portions of the implant 810. Also, in some embodiments,lateral edges of the implant 810 proximate the vagina of the patient maybe cut.

The manipulator 830 may then be removed from the vagina of the patient.

In some embodiments, a medical device includes an elongate memberconfigured to be at least partially disposed within a body of a patient.The elongate member has an outer surface. The outer surface of theelongate member having a first ridge and a second ridge.

In some embodiments, the elongate member defines a longitudinal axis,the first ridge extends in a direction parallel to the longitudinal axisof the elongate member. In some embodiments, the elongate member definesa longitudinal axis, the first ridge extends in a direction parallel tothe longitudinal axis of the elongate member, the second ridge extendsin a direction parallel to the longitudinal axis of the elongate member.

In some embodiments, the outer surface of the elongate member has afirst trough disposed on a first side of the first ridge and a secondtrough disposed on a second side of the first ridge. In someembodiments, the outer surface of the elongate member has a first troughdisposed on a first side of the first ridge and a second trough disposedon a second side of the first ridge, the first trough extends in adirection parallel to a longitudinal axis of the elongate member.

In some embodiments, the elongate member defines a lumen configured tobe operatively coupled to a vacuum source. In some embodiments, theelongate member defines a lumen that extends from a first openingdefined the elongate member to a second opening defined by the elongatemember, the first opening being disposed proximate a first end portionof the elongate member, the second opening being disposed proximate atrough defined by the elongate member. In some embodiments, the elongatemember defines a lumen that extends from a first opening defined theelongate member to a second opening defined by the elongate member, thefirst opening being disposed proximate a first end portion of theelongate member, the second opening being disposed within a troughdefined by the elongate member. In some embodiments, the elongate memberdefines a first lumen and a second lumen, the first lumen beingconfigured to be operatively coupled to a vacuum source, the secondlumen being configured to be operatively coupled to a vacuum source.

In some embodiments, the outer surface of the elongate member has afirst trough disposed on a first side of the first ridge and a secondtrough disposed on a second side of the first ridge, the first troughextends in a direction parallel to a longitudinal axis of the elongatemember, the elongate member defines a first lumen and a second lumen,the first lumen extending from a first end portion of the elongatemember to a location proximate the first trough, the second lumenextending from the first end portion of the elongate member to alocation proximate the second trough.

In some embodiments, a medical device includes an elongate member and anexpander, the expander defining a lumen and being slidably coupled tothe elongate member, the expander having a proximal end portion and adistal end portion, the distal end portion of the expander having atapered section.

In some embodiments, the expander is configured to move from a firstposition on the elongate member to a second position on the elongatemember.

In some embodiments, the proximal end portion of the expander includes ahandle portion, a proximal end portion of the elongate member includes ahandle portion. In some embodiments, the proximal end portion of theexpander includes a handle portion, a proximal end portion of theelongate member includes a handle portion, the device being configuredto be inserted into a body of a patient such that the handle portion ofthe elongate member and the handle portion of the expander are disposedoutside of the body of the patient.

In some embodiments, a method of placing an implant within a body of apatient includes inserting a manipulator within a vagina of a patient;disposing the implant adjacent a vaginal wall of the patient; moving afirst portion of the manipulator with respect to a second portion of themanipulator to expand the vagina of the patient; and attaching theimplant to the vaginal wall of the patient.

In some embodiments, the moving includes sliding the first portion ofthe manipulator with respect to the second portion of the manipulator.In some embodiments, the disposing includes disposing the manipulatorwithin the vagina of the patient such that a handle portion of the firstportion of the manipulator is disposed outside of the vagina of thepatient and a handle portion of the second portion of the manipulator isdisposed outside of the vagina of the patient. In some embodiments, theattaching includes suturing the implant to the vaginal wall of thepatient. In some embodiments, the disposing the implant adjacent thevaginal wall of the patient includes inserting a portion of the vaginalwall into a lumen defined by the implant. In some embodiments, themoving includes moving the first portion of the manipulator from a firstposition with respect to the second portion of the manipulator to asecond position, the method further including moving the first portionof the manipulator from the second position with respect to the secondportion of the manipulator to the first position; and removing themanipulator from the body of the patient.

While certain features of the described implementations have beenillustrated as described herein, many modifications, substitutions,changes and equivalents will now occur to those skilled in the art. Itis, therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the scope of theembodiments.

What is claimed is:
 1. A medical device comprising: an elongate memberconfigured to be at least partially disposed within a body of a patient,the elongate member having an outer surface, the outer surface of theelongate member having a first ridge and a second ridge.
 2. The medicaldevice of claim 1, wherein the elongate member defines a longitudinalaxis, the first ridge extends in a direction parallel to thelongitudinal axis of the elongate member.
 3. The medical device of claim1, wherein the elongate member defines a longitudinal axis, the firstridge extends in a direction parallel to the longitudinal axis of theelongate member, the second ridge extends in a direction parallel to thelongitudinal axis of the elongate member.
 4. The medical device of claim1, wherein the outer surface of the elongate member has a first troughdisposed on a first side of the first ridge and a second trough disposedon a second side of the first ridge.
 5. The medical device of claim 1,wherein the outer surface of the elongate member has a first troughdisposed on a first side of the first ridge and a second trough disposedon a second side of the first ridge, the first trough extends in adirection parallel to a longitudinal axis of the elongate member.
 6. Themedical device of claim 1, wherein the elongate member defines a lumenconfigured to be operatively coupled to a vacuum source.
 7. The medicaldevice of claim 1, wherein the elongate member defines a lumen thatextends from a first opening defined the elongate member to a secondopening defined by the elongate member, the first opening being disposedproximate a first end portion of the elongate member, the second openingbeing disposed proximate a trough defined by the elongate member.
 8. Themedical device of claim 1, wherein the elongate member defines a lumenthat extends from a first opening defined the elongate member to asecond opening defined by the elongate member, the first opening beingdisposed proximate a first end portion of the elongate member, thesecond opening being disposed within a trough defined by the elongatemember.
 9. The medical device of claim 1, wherein the elongate memberdefines a first lumen and a second lumen, the first lumen beingconfigured to be operatively coupled to a vacuum source, the secondlumen being configured to be operatively coupled to a vacuum source. 10.The medical device of claim 1, wherein the outer surface of the elongatemember has a first trough disposed on a first side of the first ridgeand a second trough disposed on a second side of the first ridge, thefirst trough extends in a direction parallel to a longitudinal axis ofthe elongate member, the elongate member defines a first lumen and asecond lumen, the first lumen extending from a first end portion of theelongate member to a location proximate the first trough, the secondlumen extending from the first end portion of the elongate member to alocation proximate the second trough.
 11. A medical device, comprising:an elongate member and an expander, the expander defining a lumen andbeing slidably coupled to the elongate member, the expander having aproximal end portion and a distal end portion, the distal end portion ofthe expander having a tapered section.
 12. The medical device of claim11, wherein the expander is configured to move from a first position onthe elongate member to a second position on the elongate member.
 13. Themedical device of claim 11, wherein the proximal end portion of theexpander includes a handle portion, a proximal end portion of theelongate member includes a handle portion.
 14. The medical device ofclaim 11, wherein the proximal end portion of the expander includes ahandle portion, a proximal end portion of the elongate member includes ahandle portion, the device being configured to be inserted into a bodyof a patient such that the handle portion of the elongate member and thehandle portion of the expander are disposed outside of the body of thepatient.
 15. A method of placing an implant within a body of a patient,comprising: inserting a manipulator within a vagina of a patient;disposing the implant adjacent a vaginal wall of the patient; moving afirst portion of the manipulator with respect to a second portion of themanipulator to expand the vagina of the patient; and attaching theimplant to the vaginal wall of the patient.
 16. The method of claim 15,wherein the moving includes sliding the first portion of the manipulatorwith respect to the second portion of the manipulator.
 17. The method ofclaim 15, wherein the disposing includes disposing the manipulatorwithin the vagina of the patient such that a handle portion of the firstportion of the manipulator is disposed outside of the vagina of thepatient and a handle portion of the second portion of the manipulator isdisposed outside of the vagina of the patient.
 18. The method of claim15, wherein the attaching includes suturing the implant to the vaginalwall of the patient.
 19. The method of claim 15, wherein the disposingthe implant adjacent the vaginal wall of the patient includes insertinga portion of the vaginal wall into a lumen defined by the implant. 20.The method of claim 15, wherein the moving includes moving the firstportion of the manipulator from a first position with respect to thesecond portion of the manipulator to a second position, the methodfurther comprising: moving the first portion of the manipulator from thesecond position with respect to the second portion of the manipulator tothe first position; and removing the manipulator from the body of thepatient.